Chromo Laboratories India Private Limited
Form 483 issued August 10, 2024 · Sangareddy, India
- Inspection
- Aug 7 – Aug 10, 2024
- Observations
- 9
- Pages
- 9
- FEI number
- 3008771562
In short: On August 10, 2024, FDA issued a Form 483 with 9 observations to Chromo Laboratories India Private Limited in Sangareddy, Telangana (FEI 3008771562) after an inspection that ran Aug 7 – Aug 10, 2024. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
6 of 9 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (3×) · 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review laboratory Out of Specification (OOS), laboratory incidents, and trends…
- 02
The responsibilities and procedures applicable to the Quality Unit are not fully established and followed. There…
- 03
There is a failure to thoroughly review and trend customer and market technical product complaints as…
- 04
Specifically, On 7/06/2024 during a walk-through inspection of the ck roduction building…
This inspection in context
Questions about this 483
What did FDA find at Chromo Laboratories India Private Limited?
FDA listed 9 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Chromo Laboratories India Private Limited inspected by FDA?
The inspection ran Aug 7 – Aug 10, 2024, and the Form 483 is dated August 10, 2024.
How do I get the full Form 483 for Chromo Laboratories India Private Limited?
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