Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal
Form 483 issued August 12, 2021 · Sangareddy, India
- Inspection
- Aug 2 – Aug 12, 2021
- Observations
- 7
- Pages
- 7
- FEI number
- 3004378446
In short: On August 12, 2021, FDA issued a Form 483 with 7 observations to Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal in Sangareddy, Telangana (FEI 3004378446) after an inspection that ran Aug 2 – Aug 12, 2021. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 5 of 7 observations.
Most cited: 21 CFR 211.160 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate specifications are not established for your API consistent with the manufacturing process. The specification does…
- 02
in} leas USP test method. You have used this USP include…
- 03
The storage condition and retest…
- 04
tudies. These specifications test methods throug! the desired scale co: The test procedure for the analysis…
This inspection in context
Questions about this 483
What did FDA find at Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal?
FDA listed 7 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal inspected by FDA?
The inspection ran Aug 2 – Aug 12, 2021, and the Form 483 is dated August 12, 2021.
How do I get the full Form 483 for Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.