Gland Chemicals Private Limited
FDA inspection history in Waluj, India, 2018
- 1
- Form 483
Every document, by year
- Form 483
2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Waluj, India.
Cited most
Across all Gland Chemicals Private Limited observations on file
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.160General requirements1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.186Master production and control records1
- 21 CFR 211.192Production record review1
The complete Gland Chemicals Private Limited file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Waluj, India
One Form 483 · 2018 · 6 observations
Latest: Form 483, Aug 7, 2018 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-08-07 | 483 Form 483 | Waluj, India | 6 | $99 |
Investigators on these documents
FEI number 3003983454 · most recent document Aug 7, 2018
About Gland Chemicals Private Limited
How many FDA Form 483s has Gland Chemicals Private Limited received?
FDA Intel has 1 Form 483 on file for Gland Chemicals Private Limited; the most recent is dated Aug 7, 2018.
When was Gland Chemicals Private Limited last inspected by FDA?
The most recent FDA inspection document on file for Gland Chemicals Private Limited is a Form 483 dated Aug 7, 2018, for the site in Waluj, India.
What did FDA cite at Gland Chemicals Private Limited?
The regulations cited most in the observations on file for Gland Chemicals Private Limited are 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.166 (Stability testing), 1 time.