DIY Fixes Don't Meet CGMP: FDA Slams Manufacturer for Fixes Involving Tape, Rubber Ba

AnaMariaVR2

Trusted Information Resource
#1
Do-it-yourself fixes are a point of pride for many, from knowledgeable handymen to frugal college students. Gutters on your house leaking? Nothing some tack welding can't fix. Rubber hose in your car sprung a leak? A quick patch with some duct tape will do in a pinch.

But as a new Warning Letter from the US Food and Drug Administration (FDA) to a dietary supplement manufacturer illustrates, shoddy DIY isn't compatible with current good manufacturing processes (CGMP).


N.V.E. Pharmaceuticals, Inc. 7/22/13
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm364258.htm

 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
AnaMariaVR2 Biopunk: DIY Scientists Hack the Software of Life Book, Video, Blog and Web Site Reviews and Recommendations 1
A Software bug fixes after shipping a product EU Medical Device Regulations 3
K Is a change that fixes a recalled device significant? Medical Device and FDA Regulations and Standards News 2
W IMDS - Help (Common Warning and Error Fixes) RoHS, REACH, ELV, IMDS and Restricted Substances 9
A Software Medical Device Bug Fixes: Correction or Corrective Action? Other US Medical Device Regulations 5
E Poor Manufacturing Planning fixes Misc. Quality Assurance and Business Systems Related Topics 4
M Internal NCR - Welded steel - Fixes during welding process Nonconformance and Corrective Action 6
D MDR fixes - Resolutions to MDR's for out-of-contract customers ISO 13485:2016 - Medical Device Quality Management Systems 2
N Writing Risk Management procedure for small manufacturing and we don't know where to start. Manufacturing and Related Processes 9
J Document Changes that don't have to be approved Document Control Systems, Procedures, Forms and Templates 11
PQ Systems Scaling Up? Don't Leave SPC Behind Using SQCpack Software 0
J WAIVED ON Q1 - We Don't have to comply with FORDS customer specific requirements IATF 16949 - Automotive Quality Systems Standard 3
S Records - Do's and don't' of record entries (FDA - 21 CFR 820) Records and Data - Quality, Legal and Other Evidence 13
F What to do when you don't meet the 1:10 ratio Measurement Uncertainty (MU) 3
MDD_QNA Accessory or I-don't-know-what-to-call-it-at-this-point EU Medical Device Regulations 3
S ARMY AQL - Requirements which don't have an AQL associated with them Manufacturing and Related Processes 2
D First 510(k) Submission - Don't Forget Tips US Food and Drug Administration (FDA) 5
M IATF 16949:2016 clause 8.4.2.3 - We don't have ISO 9001:2015 certificate IATF 16949 - Automotive Quality Systems Standard 26
I "We don't have enough resources" as an Audit Non-conformance Response General Auditing Discussions 14
D PPAP a Rebranded Purchased Product (we don't manufacture) IATF 16949 - Automotive Quality Systems Standard 6
I Importing prototype without CE (dos and don'ts ) EU Medical Device Regulations 11
H Embedded Software - I don't understand that Calibration and Metrology Software and Hardware 2
N How to ensure our employees don’t grab and use the wrong materials Manufacturing and Related Processes 11
J We don't have enough Corrective action entries AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
L Nonconformity's risk is too low, so don't report it? General Auditing Discussions 25
K RAPS RAC - Resources to prep for the RAC exam that don't cost an arm and a leg Professional Certifications and Degrees 4
M A non-religious country, where you don't drink? Coffee Break and Water Cooler Discussions 14
Jim Wynne Don't Pay the Ransom Coffee Break and Water Cooler Discussions 11
AnaMariaVR2 Warning ? Don?t Confuse ?Made In USA? And ?Inspected By FDA? With Patriotism US Food and Drug Administration (FDA) 3
Stijloor American airports don't rank very well. Travel - Hotels, Motels, Planes and Trains 13
S Don't Forget Canadian Provincial Electrical Code Requirements Canada Medical Device Regulations 1
R EU-countries which don't accept English user manuals and require national translation CE Marking (Conformité Européene) / CB Scheme 9
B You don't need to know the distribution in order to apply SPC Statistical Analysis Tools, Techniques and SPC 10
B Why don't we have more representation from Registrars at The Cove? Registrars and Notified Bodies 14
1 I don?t have any experience with ISO 9001 - Help Quality Manager and Management Related Issues 9
Wes Bucey Passing on slick roads - DON'T! Coffee Break and Water Cooler Discussions 6
BradM The Great Soul Train Conductor Don Cornelius-Dead World News 4
G ISO 17025 - Don't think we need a Sampling Plan... Or do we? ISO 17025 related Discussions 3
H ISO 9001 Section 7 when you don't manufacture anything? Service Industry Specific Topics 6
S Some departments don't have Quality Objectives - Non Conformity? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 68
A "Do's" and "Don'ts" of auditing a former employer General Auditing Discussions 12
Wes Bucey Job recovery? or "statistics don't lie, people do" Career and Occupation Discussions 37
C Old QMS... NEW QM.. I don't know where to start Quality Manager and Management Related Issues 57
Wes Bucey "Making the case" & Networking - Do's & Don't's Career and Occupation Discussions 2
M How do I prove I don't receive a controlled product? Ractopamine Hydrochloride Misc. Quality Assurance and Business Systems Related Topics 4
S ISO 9001 prohibits auditors auditing their 'own work' while other standards don't? Internal Auditing 59
M Suggestion System - Do's & Don'ts as well as Rewards System Manufacturing and Related Processes 29
BradM Just pretend you don't know about computers Funny Stuff - Jokes and Humour 1
R Definition Basic Dimensions - What are basic dimensions? Why don't they have tolerances? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 14
J Control of Product Drawings - Engineers don't follow the same protocol ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21

Similar threads

Top Bottom