Symbiotec Pharmalab Private Limited
FDA inspection history in Pithampur, India, 2017 to 2022
- 3
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2019: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Two Form 483s, at Pithampur, India.
- 2022One Form 483, at Pithampur, India.
- 2022The longest 483 on file: 6 observations over 8 pages at Pithampur, India.
Cited most
Across all Symbiotec Pharmalab Private Limited observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.160General requirements2
- 21 CFR 211.166Stability testing2
- 21 CFR 211.67Equipment cleaning and maintenance2
The complete Symbiotec Pharmalab Private Limited 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
Pithampur, India
Three Form 483s · 2017 to 2022 · 16 observations
Latest: Form 483, Sep 30, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-09-30 | 483 Form 483 | Pithampur, India | 6 | $99 |
| 2019-07-05 | 483 Form 483 | Pithampur, India | 4 | $99 |
| 2017-05-05 | 483 Form 483 | Pithampur, India | 6 | $99 |
Investigators on these documents
Christopher Keating (1)Rajiv R. Srivastava (1)Ralph H. Vocque (1)Saleem A. Akhtar (1)Satheesh Thomas (1)
FEI number 3009298759 · most recent document Sep 30, 2022
About Symbiotec Pharmalab Private Limited
How many FDA Form 483s has Symbiotec Pharmalab Private Limited received?
FDA Intel has 3 Form 483s on file for Symbiotec Pharmalab Private Limited; the most recent is dated Sep 30, 2022.
When was Symbiotec Pharmalab Private Limited last inspected by FDA?
The most recent FDA inspection document on file for Symbiotec Pharmalab Private Limited is a Form 483 dated Sep 30, 2022, for the site in Pithampur, India.
What did FDA cite at Symbiotec Pharmalab Private Limited?
The regulations cited most in the observations on file for Symbiotec Pharmalab Private Limited are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 2 times; 21 CFR 211.160 (General requirements), 2 times.