Pallimed Solutions, Inc. 400
FDA inspection history in Woburn, Massachusetts, 2013 to 2014
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2013: one amended 483; 2014: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–14One amended 483 and one warning letter, at Woburn, Massachusetts.
Cited most
Across all Pallimed Solutions, Inc. 400 observations on file
- 21 CFR 211.42(b)Design and construction features3
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.137(a)Expiration dating1
- 21 CFR 211.192Production record review1
The complete Pallimed Solutions, Inc. 400 file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Woburn, Massachusetts
One warning letter and one amended 483 · 2013 to 2014 · 13 observations
Latest: Warning letter, Feb 19, 2014 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2014-02-19 | Warning letter Warning letter | Woburn, Massachusetts | — | $99 |
| 2013-04-09 | Amended 483 Amended 483 | Woburn, Massachusetts | 13 | $99 |
Investigators on these documents
FEI number 3010084286 · most recent document Feb 19, 2014
About Pallimed Solutions, Inc. 400
How many FDA Form 483s has Pallimed Solutions, Inc. 400 received?
FDA Intel has 1 Form 483 on file for Pallimed Solutions, Inc. 400; the most recent is dated Apr 9, 2013.
When was Pallimed Solutions, Inc. 400 last inspected by FDA?
The most recent FDA inspection document on file for Pallimed Solutions, Inc. 400 is a Form 483 dated Apr 9, 2013, for the site in Woburn, Massachusetts.
What did FDA cite at Pallimed Solutions, Inc. 400?
The regulations cited most in the observations on file for Pallimed Solutions, Inc. 400 are 21 CFR 211.42(b) (Design and construction features), 3 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time.
Has Pallimed Solutions, Inc. 400 received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Pallimed Solutions, Inc. 400; the most recent is dated Feb 19, 2014.