Ohm Laboratories, Inc.
FDA inspection history in Gloversville, New York, 2009
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2009: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2009One warning letter and one Form 483, at Gloversville, New York.
Cited most
Across all Ohm Laboratories observations on file
- 21 CFR 211.166Stability testing4
- 21 CFR 211.194Laboratory records3
- 21 CFR 211.160General requirements2
- 21 CFR 211.25Personnel qualifications2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
The complete Ohm Laboratories 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
Gloversville, New York
One warning letter and one Form 483 · 2009 · 24 observations
Latest: Warning letter, Dec 21, 2009 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2009-12-21 | Warning letter Warning letter | Gloversville, New York | — | $99 |
| 2009-08-12 | 483 Form 483 | Gloversville, New York | 24 | $99 |
Investigators on these documents
FEI number 3001236657 · most recent document Dec 21, 2009
About Ohm Laboratories, Inc.
How many FDA Form 483s has Ohm Laboratories, Inc. received?
FDA Intel has 1 Form 483 on file for Ohm Laboratories, Inc.; the most recent is dated Aug 12, 2009.
When was Ohm Laboratories, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Ohm Laboratories, Inc. is a Form 483 dated Aug 12, 2009, for the site in Gloversville, New York.
What did FDA cite at Ohm Laboratories, Inc.?
The regulations cited most in the observations on file for Ohm Laboratories, Inc. are 21 CFR 211.166 (Stability testing), 4 times; 21 CFR 211.194 (Laboratory records), 3 times; 21 CFR 211.160 (General requirements), 2 times.
Has Ohm Laboratories, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Ohm Laboratories, Inc.; the most recent is dated Dec 21, 2009.