NeilMed Pharmaceuticals, Inc
FDA inspection history in Santa Rosa, California, 2022 to 2023
- 1
- Warning letter
- 1
- Form 483
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2022: one Form 483; 2023: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–23One Form 483 and one warning letter, at Santa Rosa, California.
Cited most
Across all NeilMed Pharmaceuticals observations on file
- 21 CFR 211.22(a)Responsibilities of quality control unit2
- 21 CFR 211.192Production record review1
- 21 CFR 211.67(a)Equipment cleaning and maintenance1
- 21 CFR 211.84(d)(1)Testing and approval or rejection of components, drug product containers, and closures1
The complete NeilMed Pharmaceuticals file.
All 3 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
Santa Rosa, California
One warning letter, one Form 483 and one close-out letter · 2022 to 2023 · 5 observations
Latest: Warning letter, May 26, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-05-26 | Warning letter Warning letter | Santa Rosa, California | — | $99 |
| 2022-12-02 | 483 Form 483 | Santa Rosa, California | 5 | $99 |
| Undated | Close-out Close-out letter | Santa Rosa, California | — | $99 |
Investigators on these documents
FEI number 3002998723 · most recent document May 26, 2023
About NeilMed Pharmaceuticals, Inc
How many FDA Form 483s has NeilMed Pharmaceuticals, Inc received?
FDA Intel has 1 Form 483 on file for NeilMed Pharmaceuticals, Inc; the most recent is dated Dec 2, 2022.
When was NeilMed Pharmaceuticals, Inc last inspected by FDA?
The most recent FDA inspection document on file for NeilMed Pharmaceuticals, Inc is a Form 483 dated Dec 2, 2022, for the site in Santa Rosa, California.
What did FDA cite at NeilMed Pharmaceuticals, Inc?
The regulations cited most in the observations on file for NeilMed Pharmaceuticals, Inc are 21 CFR 211.22(a) (Responsibilities of quality control unit), 2 times; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.67(a) (Equipment cleaning and maintenance), 1 time.
Has NeilMed Pharmaceuticals, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for NeilMed Pharmaceuticals, Inc; the most recent is dated May 26, 2023.