Colgate-Palmolive India Ltd.’
Form 483 issued May 3, 2019 · Mumbai, India
- Inspection
- Apr 30 – May 3, 2019
- Investigator
- Truong X. Nguyen
- Observations
- 2
- Pages
- 2
- FEI number
- 3004698222
In short: On May 3, 2019, FDA issued a Form 483 with 2 observations to Colgate-Palmolive India Ltd.’ in Mumbai, Maharashtra (FEI 3004698222) after an inspection that ran Apr 30 – May 3, 2019. The investigator was Truong X. Nguyen. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.194(a)(4) (1×) · 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory records are deficient in that they do not include a complete record of all data…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Truong X. Nguyen
20 documents · 2011–2026
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmColgate-Palmolive India Ltd.’ history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.194(a)(4)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Colgate-Palmolive India Ltd.’?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Colgate-Palmolive India Ltd.’?
Truong X. Nguyen is named on this Form 483, for the inspection of Apr 30 – May 3, 2019. Each investigator has a profile showing what they cite most.
When was Colgate-Palmolive India Ltd.’ inspected by FDA?
The inspection ran Apr 30 – May 3, 2019, and the Form 483 is dated May 3, 2019.
How do I get the full Form 483 for Colgate-Palmolive India Ltd.’?
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.