483
Hetero Labs Limited - Unit IIIFDA 483 - Hetero Labs Limited - Unit III - October 26, 2016
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Record Details
Hetero Labs, Ltd. - Unit III received a Form 483 for significant deficiencies in laboratory controls and record-keeping. The firm failed to use validated and transferred analytical methods for various product testing stages and did not adequately investigate out-of-trend results. Additionally, laboratory records were incomplete and lacked proper documentation practices.
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