Chromo Laboratories India Private Limited
Form 483 issued January 24, 2020 · Sangareddy, India
- Inspection
- Jan 22 – Jan 24, 2020
- Investigator
- Yasamin Ameri
- Observations
- 9
- Pages
- 5
- FEI number
- 3008771562
In short: On January 24, 2020, FDA issued a Form 483 with 9 observations to Chromo Laboratories India Private Limited in Sangareddy, Telangana (FEI 3008771562) after an inspection that ran Jan 22 – Jan 24, 2020. The investigator was Yasamin Ameri. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and laboratory controls account for 7 of 9 observations.
Most cited: 21 CFR 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
Input and out form the computerized systems should…
- 02
Appropriate analytical methods should be used in analysis of…
- 03
An expiry or retest date for intermediates that are transferred outside of the manufacturer’s control should…
- 04
There is a failure to thoroughly review laboratory incidents and trends…
This inspection in context
Yasamin Ameri
20 documents · 2015–2022
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in India.
The firmChromo Laboratories India Private Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chromo Laboratories India Private Limited?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Chromo Laboratories India Private Limited?
Yasamin Ameri is named on this Form 483, for the inspection of Jan 22 – Jan 24, 2020. Each investigator has a profile showing what they cite most.
When was Chromo Laboratories India Private Limited inspected by FDA?
The inspection ran Jan 22 – Jan 24, 2020, and the Form 483 is dated January 24, 2020.
How do I get the full Form 483 for Chromo Laboratories India Private Limited?
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.