OHM PHARMA INC.
FDA inspection history in Mineral Wells, Texas, 2019 to 2020
- 2
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2019: one close-out letter and one Form 483; 2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–20Two Form 483s and one close-out letter, at Mineral Wells, Texas.
- 2019The longest 483 on file: 6 observations over 7 pages at Mineral Wells, Texas.
Cited most
Across all OHM PHARMA observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 111.77What must you do if established specifications are not met?1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.192Production record review1
- 21 CFR 211.194Laboratory records1
The complete OHM PHARMA 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
Mineral Wells, Texas
Two Form 483s and one close-out letter · 2019 to 2020 · 7 observations
Latest: Form 483, Mar 18, 2020 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-03-18 | 483 Form 483 | Mineral Wells, Texas | 1 | $99 |
| 2019-11-19 | Close-out Close-out letter | Mineral Wells, Texas | — | $99 |
| 2019-05-23 | 483 Form 483 | Mineral Wells, Texas | 6 | $99 |
Investigators on these documents
FEI number 3003231743 · most recent document Mar 18, 2020
About OHM PHARMA INC.
How many FDA Form 483s has OHM PHARMA INC. received?
FDA Intel has 2 Form 483s on file for OHM PHARMA INC.; the most recent is dated Mar 18, 2020.
When was OHM PHARMA INC. last inspected by FDA?
The most recent FDA inspection document on file for OHM PHARMA INC. is a Form 483 dated Mar 18, 2020, for the site in Mineral Wells, Texas.
What did FDA cite at OHM PHARMA INC.?
The regulations cited most in the observations on file for OHM PHARMA INC. are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 111.77 (What must you do if established specifications are not met?), 1 time; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time.