CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED
FDA inspection history in Shamshabad, India, 2022 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2022: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–23Two Form 483s, at Shamshabad, India.
- 2022The longest 483 on file: 6 observations over 16 pages at Shamshabad, India.
Cited most
Across all CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED observations on file
- 21 CFR 211.113(b)Control of microbiological contamination2
- 21 CFR 211.22(c)Responsibilities of quality control unit2
- 21 CFR 211.100(b)Written procedures; deviations1
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.42(a)Design and construction features1
The complete CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED 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
Shamshabad, India
Two Form 483s · 2022 to 2023 · 8 observations
Latest: Form 483, Aug 29, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-08-29 | 483 Form 483 | Shamshabad, India | 2 | $99 |
| 2022-01-15 | 483 Form 483 | Shamshabad, India | 6 | $99 |
Investigators on these documents
FEI number 3015283219 · most recent document Aug 29, 2023
About CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED
How many FDA Form 483s has CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED received?
FDA Intel has 2 Form 483s on file for CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED; the most recent is dated Aug 29, 2023.
When was CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED last inspected by FDA?
The most recent FDA inspection document on file for CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED is a Form 483 dated Aug 29, 2023, for the site in Shamshabad, India.
What did FDA cite at CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED?
The regulations cited most in the observations on file for CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED are 21 CFR 211.113(b) (Control of microbiological contamination), 2 times; 21 CFR 211.22(c) (Responsibilities of quality control unit), 2 times; 21 CFR 211.100(b) (Written procedures; deviations), 1 time.