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    FDA chides Valisure for DSCSA, analytical testing issues

    The US Food and Drug Administration (FDA) recently sent an untitled letter to Connecticut-based contract testing lab Valisure for failing to comply with the Drug Supply Chain Security Act (DSCSA) and for findings of “methodological deficiencies” in the company’s analytical testing laboratory.   FDA’s action targets a company that played a role in several recent high-profile recalls after it raised concerns about the levels of possible carcinogenic impurities found in...
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    FDA says Abraxis failed to proactively address repeat media fill contamination issues

    The US Food and Drug Administration (FDA) blasted Abraxis Biosciences in a recent warning letter for not addressing recurring media fill failures in its aseptic processing operations of the sterile drug Abraxane and for failing to conduct robust follow-up investigations to determine the root cause of these multiple failures.   During a one-week inspection conducted in late March at the firm’s site in Phoenix, AZ, the agency observed “multiple media fill failures” in th...
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    FDA warns US sterile injectable maker on contamination controls, another US maker warned for poor building conditions

    Two domestic drug manufacturers were lambasted in recent warning letters sent by the US Food and Drug Administration (FDA) for good manufacturing practice (GMP) violations; one was told to adopt better contamination controls and to keep outsourced drugs separate from those made at the facility, while another was reprimanded for keeping the facility in a poor state of repair.   FDA also targeted two firms for failing to file accurate product information in its electroni...
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    FDA warns German OTC firm, Chinese API maker for lax cleaning practices, other GMP issues

    A German manufacturer of OTC products and a Chinese supplier of active pharmaceutical ingredients (APIs) were told to adopt better equipment cleaning practices in recent warning letters from the US Food and Drug Administration (FDA). The letters, posted on 27 September, also identified a slew of other current good manufacturing practice (CGMP) violations.   The first warning letter, to System Kosmetik Produktionsgesellschaft fur kosmetische, located in Munster, Germany...
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    Warning letters: Investigators refused entry to testing lab; firm cited for distributing unauthorized COVID tests

    The US Food and Drug Administration (FDA) chastised a San Diego, California based testing lab in a recent warning letter for “significant deviations” from current good manufacturing practices (GMPs), including initially blocking investigators from entering the site, making false statements, failing to adequately the suitability of its analytical methods for testing products and lacking adequate safeguards over computer equipment.   In another recent warning letter, the...
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    FDA blasts US API firm for lax response to mold contamination, data integrity failings

    A US manufacturer of active pharmaceutical ingredients (API) was lambasted in a recent warning letter by the US Food and Drug Administration (FDA) for multiple good manufacturing practice (GMP) violations, one of which was a failure to adequately respond to mold contamination.   The firm also failed to maintain control over its computer systems to prevent unauthorized access to electronic data.   The warning letter was issued on 18 July to St. Louis-based manufactu...
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    FDA warning letter tells Spanish API firm to up its validation game

    A Spanish producer of active pharmaceutical ingredients (API) was chastised by the US Food and Drug Administration (FDA) in a June 30 warning letter for its spotty approach to validation and ensuring that manufacturing processes remain in a state of control and can consistently produce a quality product.   The letter to Bioiberica SAU in Barcelona, Spain, which makes heparin-based products, in addition to APIs, follows an inspection between 31 January and 4 February ...
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    FDA tells Dutch API producer to clean up its equipment act

    A Dutch producer of active pharmaceutical ingredients (APIs) was put on notice to adopt more robust equipment cleaning practices and use better safeguards to prevent cross-contamination in a warning letter from the US Food and Drug Administration (FDA) dated 14 June. FDA found the presence of “visible powder residue” on non-dedicated equipment.   The warning letter pertained to Fagron Group B.V.’s manufacturing site in Saint Paul, MN. The company is headquartered in ...
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    Experts say FDA enforcement focus unchanged, use of alternative tools to grow

    The US Food and Drug Administration (FDA) will continue to focus on data integrity practices and take a hard look at OTC firms’ testing programs either through onsite inspections or using alternative inspection tools in fiscal year 2022, according to experts who spoke to Regulatory Focus on near-term enforcement trends.   In addition, industry should expect to continue fielding requests for electronic records as the agency’s use of this alternative inspection tool is...
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    Chinese firm warned for making OTC eye drops without microbiological safeguards

    The US Food and Drug Administration (FDA) warned Chinese drugmaker Hubei Kangzheng for having inadequate microbiological controls to prevent contamination of its over-the-counter (OTC) eye drops. These violations partly stem from the firm’s misguided notion that the eye drops are non-sterile drugs, thus not to more stringent microbiological controls.   The warning letter was issued on 23 November 2021 and posted to FDA’s website on 11 January. It follows a nine-day ins...
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    Smiths Medical warned by FDA for multiple violations

    The US Food and Drug Administration (FDA) slapped Smiths Medical in Minneapolis, MN with a warning letter for inadequate procedures for handling medical device reports (MDRs), faulty handling of complaints, inadequate validation processes, and lax corrective and preventative actions (CAPA) procedures. The company makes blood warmers and infusion pumps.   The warning letter was issued on 1 October and posted on 23 November. It follows a recent recall of the company’s ...
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    Wound dressing firm warned for design, environmental control issues

    An Ohio firm that is both an own-label distributor and specification developer of sterile wound dressings received a warning letter from the US Food and Drug Administration (FDA) for ongoing problems including a lack of medical device reporting procedures, design control issues, and lack of document and environmental control, among others.   CellEra LLC, which distributes wound dressings with drugs such as silver, petrolatum and collagen, received the 20 October warnin...