Hetero Labs Limited TSUC Pharma SEZ
Form 483 issued August 12, 2022 · Mahabubnagar, India
- Inspection
- Aug 4 – Aug 12, 2022
- Investigator
- Jeffrey P. Raimondi
- Observations
- 6
- Pages
- 9
- FEI number
- 3008307735
In short: On August 12, 2022, FDA issued a Form 483 with 6 observations to Hetero Labs Limited TSUC Pharma SEZ in Mahabubnagar, Telangana (FEI 3008307735) after an inspection that ran Aug 4 – Aug 12, 2022. The investigator was Jeffrey P. Raimondi. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Written records of investigation of a drug complaint do not include the findings of the…
- 03
An®@-Field Alert Report was not submitted within three working days of receipt of information concerning a…
- 04
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training…
This inspection in context
Jeffrey P. Raimondi
40 documents · 2017–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmHetero Labs Limited TSUC Pharma SEZ history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hetero Labs Limited TSUC Pharma SEZ?
FDA listed 6 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Hetero Labs Limited TSUC Pharma SEZ?
Jeffrey P. Raimondi is named on this Form 483, for the inspection of Aug 4 – Aug 12, 2022. Each investigator has a profile showing what they cite most.
When was Hetero Labs Limited TSUC Pharma SEZ inspected by FDA?
The inspection ran Aug 4 – Aug 12, 2022, and the Form 483 is dated August 12, 2022.
How do I get the full Form 483 for Hetero Labs Limited TSUC Pharma SEZ?
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.